This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under 0003015876-2021-01044.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) (b)(4) of the european parliament and of the council.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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